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Through a Humanitarian Device Exemption, Reclaim™ DBS Therapy for OCD* is available for use as an adjunct to medication and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).
Reclaim DBS Therapy for OCD may help manage your symptoms, but it is not a cure. When your DBS system is turned on, it will deliver stimulation that may decrease your OCD symptoms. If stimulation is discontinued, symptoms will likely return.
Risks of Reclaim DBS Therapy can include risks of brain surgery, stimulation side effects, or device complications.
Your doctor can provide more information about these and other potential risks and side effects. Many side effects related to stimulation can be managed by adjusting the stimulation settings. Several follow-up visits may be needed to find the best stimulation settings.
Additionally, neurostimulator batteries will need to be replaced after a period of months or years, depending on the level of stimulation you require. The battery can be replaced in a surgical procedure that does not require an overnight stay in the hospital.
DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, stroke, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through your skin, and the lead or lead/extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return or worsen.
Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms. In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.
Your doctor should carefully monitor you for symptoms of depression, anxiety, and/or hypomania/mania. Such symptoms may include changes in sleep or eating behavior, disinhibition, anger, aggression, and a predisposition to accidents.
There is also potential for brain tissue damage if the stimulation parameters are set too high. Your physician will be warned when the stimulation parameters exceed a certain charge density.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
Humanitarian Device: Authorized by Federal (U.S.A.) law for use as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this device for this use has not been demonstrated.